Is pravastatin (generic name) safe during pregnancy?

From the Guidelines

Pravastatin should only be considered during pregnancy if the potential benefits clearly outweigh the risks, particularly in cases of high-risk pregnant patients with homozygous familial hypercholesterolemia or those at very high risk of heart attack or stroke 1. When managing cholesterol during pregnancy, it's essential to prioritize the potential risks and benefits of statin therapy, including pravastatin.

• The FDA has removed the contraindication against the use of statins in all pregnant patients, allowing healthcare professionals and patients to make individual decisions about benefit and risk 1.
• Recent large observational studies have not demonstrated evidence of harm to mother or fetus with statin use, and the safety of pravastatin has been under study for the prevention of pre-eclampsia in high-risk pregnant women 1.
• However, the use of statins during pregnancy should be approached with caution, and alternative medications with better safety profiles might be considered under close medical supervision 1.
• Lifestyle modifications, such as a heart-healthy diet, regular exercise, and weight management, are the preferred approaches for managing cholesterol during pregnancy 1.
• In cases where treatment of hyperlipidemia is absolutely necessary during pregnancy, a shared decision-making process between the patient and their healthcare provider should be undertaken to discuss the risks and benefits of statin therapy, including pravastatin 1.

From the FDA Drug Label

Discontinue pravastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient Pravastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, pravastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations Published data from prospective and retrospective observational cohort studies with pravastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage

Pravastatin use in pregnancy is not recommended due to the potential risk of fetal harm.

• The drug label advises to discontinue pravastatin when pregnancy is recognized.
• There is insufficient data to determine the risk of miscarriage associated with pravastatin use in pregnant women 2 2.
• Treatment of hyperlipidemia is not generally necessary during pregnancy.

From the Research

Pravastatin Use in Pregnant Women

• Pravastatin has been studied as a potential preventive measure for preeclampsia in high-risk pregnant women 3, 4, 5.
• The studies suggest that pravastatin may be safe for use in pregnant women, with no significant differences in adverse events or congenital anomalies compared to placebo 3, 5.
• Pravastatin has been shown to have a favorable effect on pregnancy outcomes, including a reduced risk of preeclampsia and preterm delivery 3, 5.

Pharmacokinetics of Pravastatin in Pregnancy

• The pharmacokinetics of pravastatin have been studied in pregnant women, with results showing that pravastatin renal clearance is significantly higher in pregnancy compared to postpartum 3.
• The majority of umbilical cord and maternal pravastatin plasma concentrations at the time of delivery were below the lower limit of quantification of the assay 3, 5.
• The apparent oral clearance, half-life, and time to reach maximum concentration of pravastatin were similar in pregnant and nonpregnant women 5.

Safety and Efficacy of Pravastatin in Pregnancy

• The available evidence suggests that pravastatin may be a useful and safe alternative for preventing and treating preeclampsia during pregnancy 6, 7.
• However, the effectiveness of pravastatin in preventing and treating preeclampsia needs to be confirmed by larger, well-designed clinical trials 6, 7.
• The current evidence is based on small pilot studies and preclinical data, and more research is needed to fully understand the safety and efficacy of pravastatin in pregnant women 3, 4, 5, 6, 7.